NCT05397626

Biofeedback and Hydrogen Water as Treatments for Chronic Fatigue Syndrome

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 39 (estimated)
• Sponsor: Stony Brook University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The aim of this 10-week pilot study is to explore the potential benefit of two recently developed non-invasive interventions, heart rate variability biofeedback (HRV-BF) and OTC supplement hydrogen water, for the symptoms of chronic fatigue syndrome (CFS). Symptom measures and heart monitoring information will be generated by this study. Given the lack of effective treatments in this illness, these two non-invasive home-based treatments may help patients feel and function better.

Detailed description

The aim of this 10-week pilot study is to explore the potential benefit of two recently developed non-invasive interventions, heart rate variability biofeedback (HRV-BF) and over the counter (OTC) supplement hydrogen water, for the symptoms of chronic fatigue syndrome (CFS). Symptom measures and heart monitoring information will be generated by this study. Given the lack of effective treatments in this illness, these two non-invasive home-based treatments may help patients feel and function better. Participants will be randomized to one of the three study condition, HRV-BF alone, hydrogen water alone or combined HRV-BF and hydrogen water. All interventions are home-based with no in person visits. All communications with participants will be via virtual call, phone call, email and land mail.

Conditions

• Chronic Fatigue Syndrome

Interventions

Type	Name	Description
BEHAVIORAL	Heart Rhythm Biofeedback	Heart rhythm biofeedback is a non-invasive intervention intended to improve heart rate variability and physical resilience that is often limited in chronic fatigue syndrome
DIETARY_SUPPLEMENT	Hydrogen Water	Hydrogen water, if ingested daily over several weeks, may have antioxidant and anti-inflammatory effects in chronic fatigue syndrome
COMBINATION_PRODUCT	Combined treatment: Heart rhythm biofeedback plus hydrogen water	This treatment is intended to explore the possible additive or synergistic effects of combining heart rhythm biofeedback and hydrogen water.

Timeline

• Start date: 2022-05-23
• Primary completion: 2023-05-23
• Completion: 2023-05-23
• First posted: 2022-05-31
• Last updated: 2022-05-31

Locations

1 site across 1 country: United States